EMEA-000609-PIP01-09-M01
Key facts
Active substance |
Recombinant human glutamic acid decarboxylase (rhGAD65)
|
Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
Decision number |
P/0400/2017
|
PIP number |
EMEA-000609-PIP01-09-M01
|
Pharmaceutical form(s) |
Suspension for injection
|
Condition(s) / indication(s) |
Treatment of type I diabetes mellitus
|
Route(s) of administration |
Subcutaneous use
|
Contact for public enquiries |
Diamyd Therapeutics AB
|
Decision type |
RPM: decision refers to a refusal on the application for modification of an agreed PIP
|